UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 29, 2024
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission File Number) | IRS Employer | ||||||
| of incorporation or organization) | Identification No.) | |||||||
(Address of principal executive offices)
Registrant’s telephone number, including area code: (858) 952-7570
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class: | Trading Symbol(s) | Name of each exchange on which registered: | ||||||||||||
| The Nasdaq Stock Market LLC | ||||||||||||||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
1
Item 2.02 Results of Operations and Financial Conditions.
On February 29, 2024, Cardiff Oncology, Inc. (the “Company”) issued a press release announcing company highlights and financial results for the fourth quarter and full year ended December 31, 2023.
A copy of the earnings press release is furnished as Exhibit 99.1 to this Form 8-K. On February 29, 2024, members of the Company’s management will hold a fourth quarter 2023 earnings conference call to discuss the Company’s financial results and the presentation attached hereto as Exhibit 99.4 will accompany management’s comments.
Item 7.01 Regulation FD Disclosure
The information set forth in Item 2.02 above is hereby incorporated herein by reference.
On February 29, 2024, the Company issued a press release which provided a clinical update on the first release of data from its second-line RAS-mutated metastatic colorectal cancer (mCRC) ONSEMBLE trial. In addition, on February 29, 2024, the Company announced that the first patient was dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer. A copy of each press releases is furnished as Exhibits 99.2 and 99.3 to this Form 8-K, respectively.
The information in this report, including the press release and the earnings conference call presentation furnished as Exhibits 99.1, 99.2, 99.3 and 99.4 hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. In addition, the exhibits furnished herewith contain statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in such exhibits.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| 99.1 | |||||
| 99.2 | |||||
| 99.3 | |||||
| 99.4 | |||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | ||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: February 29, 2024
| CARDIFF ONCOLOGY, INC. | ||||||||
| By: | /s/ Mark Erlander | |||||||
| Mark Erlander | ||||||||
| Chief Executive Officer | ||||||||
2
Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update
- First patient dosed in Phase 2 first-line trial in patients with RAS-mutated mCRC for new lead program with the support of FDA and clinical execution from Pfizer Ignite -
- Interim topline data from first-line RAS-mutated mCRC trial is expected in mid-2024 -
- New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in bev naïve RAS-mutated mCRC patients -
- Cash and equivalents of $75 million as of December 31, 2023, projected runway into Q3 2025 -
- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -
SAN DIEGO, February 29, 2024 -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
“2024 is a pivotal year for Cardiff Oncology and we are excited for our upcoming randomized data readout from our lead program in first-line mCRC later this year,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “The mCRC data we shared in August 2023, and the ONSEMBLE data we are disclosing today, demonstrates onvansertib’s contribution to the standard of care of bevacizumab (bev) and chemotherapy in treating RAS-mutated mCRC. Given there have been no new therapies approved in this large cancer indication in the last 20 years, 2024 marks a critical step in realizing onvansertib’s potential to provide clinical benefit to the large number of newly-diagnosed RAS-mutated mCRC patients, and create value for the stakeholders in our company.”
Upcoming expected milestones
•First-line RAS-mutated mCRC randomized data readout expected in mid-2024
Company highlights for the quarter ended December 31, 2023, and subsequent weeks include:
•Provided a clinical update on Phase 2 randomized second-line ONSEMBLE trial in mCRC. New clinical data from discontinued second-line randomized ONSEMBLE trial provides further evidence of onvansertib’s improvement of the efficacy for standard of care therapy in bev naïve patients. In the trial, patients who were bev naïve demonstrated an objective response rate (ORR) of 50% on onvansertib. No clinical responses were observed in patients who received standard of care with FOLFIRI/bev or patients who were previously exposed to bev. For additional information, please refer to the press release issued by the Company today which provided an update on the ONSEMBLE trial.
•Announced first patient dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer. The trial, whose clinical execution is being conducted by Pfizer Ignite, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard of care (SoC) vs. SoC alone. Interim topline results from CRDF-004 are expected in mid-2024. Contingent upon the results, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent.
•Announced the publication of data from Phase 1b study in second line KRAS-mutated mCRC in Clinical Cancer Research. The findings of the Phase 1b portion of the Phase 1b/2 study for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer disclosed by Cardiff Oncology
in August 2023 have been published in the peer-reviewed journal Clinical Cancer Research, a journal of the American Association for Cancer Research.
Full Year 2023 Financial Results:
Liquidity, cash burn, and cash runway
As of December 31, 2023, Cardiff Oncology had approximately $75 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the full year 2023 was approximately $30.9 million, a decrease of approximately $2.9 million from $33.8 million for the same period in 2022.
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q3 2025.
Operating results
Total operating expenses were approximately $45.9 million for the full year ended December 31, 2023, an increase of $5.6 million from $40.3 million for the same period in 2022. The increase in operating expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, and higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.
Conference Call and Webcast
Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company's website following the completion of the call.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued
due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com
Media Contact:
Richa Kumari
Taft Communications
551-344-5592
richa@taftcommunications.com
Cardiff Oncology, Inc.
Condensed Statements of Operations
(in thousands, except for per share amounts)
| Year Ended December 31, | |||||||||||
| 2023 | 2022 | ||||||||||
| Royalty revenues | $ | 488 | $ | 386 | |||||||
| Costs and expenses: | |||||||||||
| Research and development | 32,857 | 27,107 | |||||||||
| Selling, general and administrative | 13,043 | 13,181 | |||||||||
| Total operating expenses | 45,900 | 40,288 | |||||||||
| Loss from operations | (45,412) | (39,902) | |||||||||
| Interest income, net | 4,069 | 1,581 | |||||||||
| Other expense, net | (98) | (383) | |||||||||
| Net loss | (41,441) | (38,704) | |||||||||
| Preferred stock dividend | (24) | (24) | |||||||||
| Net loss attributable to common stockholders | $ | (41,465) | $ | (38,728) | |||||||
| Net loss per common share — basic and diluted | $ | (0.93) | $ | (0.89) | |||||||
| Weighted-average shares outstanding — basic and diluted | 44,677 | 43,600 | |||||||||
Cardiff Oncology, Inc.
Condensed Balance Sheets
(in thousands)
| December 31, 2023 | December 31, 2022 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 21,655 | $ | 16,347 | |||||||
| Short-term investments | 53,168 | 88,920 | |||||||||
| Accounts receivable and unbilled receivable | 288 | 771 | |||||||||
| Prepaid expenses and other current assets | 2,301 | 5,246 | |||||||||
| Total current assets | 77,412 | 111,284 | |||||||||
| Property and equipment, net | 1,238 | 1,269 | |||||||||
| Operating lease right-of-use assets | 1,708 | 2,251 | |||||||||
| Other assets | 1,279 | 1,387 | |||||||||
| Total Assets | $ | 81,637 | $ | 116,191 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 1,966 | $ | 1,956 | |||||||
| Accrued liabilities | 7,783 | 5,177 | |||||||||
| Operating lease liabilities | 691 | 675 | |||||||||
| Total current liabilities | 10,440 | 7,808 | |||||||||
| Operating lease liabilities, net of current portion | 1,458 | 2,040 | |||||||||
| Total Liabilities | 11,898 | 9,848 | |||||||||
| Stockholders’ equity | 69,739 | 106,343 | |||||||||
| Total liabilities and stockholders’ equity | $ | 81,637 | $ | 116,191 | |||||||
Cardiff Oncology, Inc.
Condensed Statements of Cash Flows
(in thousands)
| Year ended December 31, | |||||||||||
| 2023 | 2022 | ||||||||||
| Operating activities | |||||||||||
| Net loss | $ | (41,441) | $ | (38,704) | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Loss on disposal of fixed assets | — | 1 | |||||||||
| Depreciation | 398 | 236 | |||||||||
| Stock-based compensation expense | 4,509 | 4,256 | |||||||||
| (Accretion) amortization of (discounts) and premiums on short-term investments, net | (921) | 632 | |||||||||
| Release of clinical trial funding commitment | — | 139 | |||||||||
| Changes in operating assets and liabilities | 6,568 | (380) | |||||||||
| Net cash used in operating activities | (30,887) | (33,820) | |||||||||
| Investing activities: | |||||||||||
| Net capital expenditures | (582) | (892) | |||||||||
| Net purchases, maturities and sales of short-term investments | 36,777 | 39,041 | |||||||||
| Net cash provided by investing activities | 36,195 | 38,149 | |||||||||
| Financing activities: | |||||||||||
| Proceeds from exercise of options | — | 75 | |||||||||
| Net cash provided by financing activities | — | 75 | |||||||||
| Net change in cash and cash equivalents | 5,308 | 4,404 | |||||||||
| Cash and cash equivalents—Beginning of period | 16,347 | 11,943 | |||||||||
| Cash and cash equivalents—End of period | $ | 21,655 | $ | 16,347 | |||||||
Cardiff Oncology Provides Clinical Update on Phase 2 Randomized Second-line ONSEMBLE Trial in Patients with RAS-mutated mCRC
- New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in bev naïve RAS-mutated mCRC patients -
- Company discontinued the ONSEMBLE trial in August 2023 to shift focus of clinical development program to first-line RAS-mutated mCRC in agreement with the FDA -
- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -
SAN DIEGO, February 29, 2024 -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today provided a clinical update on the first release of data from its second-line RAS-mutated metastatic colorectal cancer (mCRC) ONSEMBLE trial. Although the Phase 2 ONSEMBLE trial was discontinued as part of the company’s shift to a first-line mCRC program, it enrolled 23 patients randomized across three arms prior to closing the trial to new enrollment. The 23 enrolled patients continued treatment per protocol. The clinical data repeats the efficacy findings of onvansertib in bev naïve patients seen in the company’s earlier Phase 1b/2 KRAS-mutated mCRC trial.
“The randomized data from the ONSEMBLE trial further validates the opportunity for onvansertib in the first-line RAS-mutated mCRC setting. The only objective responses observed on the trial occurred in bev naïve patients who received onvansertib plus standard of care, and the combination of onvansertib with standard of care was well-tolerated. By moving our lead program to the first-line setting, all patients on the CRDF-004 trial will be bev naïve,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “Importantly, no responses were observed in bev naïve patients randomized to the control arm, suggesting onvansertib improved the efficacy of standard of care therapy. And similarly, no responses were observed in patients who had received bev as part of their first line therapy in the onvansertib or the control arms, providing further evidence in a randomized setting of onvansertib’s potential to improve outcomes for patients when added to standard of care in the first-line setting. We look forward to sharing the topline results of our first-line CRDF-004 trial in mid-2024.”
Data Release from the Phase 2 randomized second-line ONSEMBLE trial in RAS-mutated mCRC
In August 2023, Cardiff Oncology discontinued enrollment in the second-line ONSEMBLE trial to focus on its new lead program in first-line RAS-mutated mCRC. This decision was driven by the fact that both trials essentially test the same clinical hypothesis, the importance of deploying the company's capital efficiently, and the FDA's suggestion that Cardiff Oncology consider focusing on the first-line RAS-mutated mCRC setting given the lack of any new therapies approved in this large cancer indication in the last 20 years.
At the time enrollment was discontinued, the ONSEMBLE trial had randomized 23 patients across three arms including a control arm of standard of care (SoC) FOLFIRI+bev, an experimental arm with onvansertib (20mg dose) added to SoC FOLFIRI+bev, and an experimental arm with onvansertib (30mg dose) added to SoC FOLFIRI+bev. The trial included patients with mCRC who had a documented KRAS or NRAS mutation and had previously received one prior chemotherapy regimen with or without bev in the first-line metastatic setting.
| Patient enrollment populations | |||||
| Intent to treat population | 23 patients | ||||
| Patient randomized to control arm withdrew consent prior to initial dose | 1 patient | ||||
| Patient population evaluable for safety | 22 patients | ||||
| Patient randomized to control arm withdrew consent prior to post-baseline scan | 1 patient | ||||
| Patient population evaluable for efficacy | 21 patients | ||||
| Efficacy Data – Objective Response Rates (ORR) | |||||||||||
| Bev Naïve patients | Bev Exposed patients | All patients | |||||||||
| FOLFIRI/bev (SoC alone); N=6 | 0% (0 of 3) | 0% (0 of 3) | 0% (0 of 6) | ||||||||
| Onvansertib 20 mg + SoC; N=8 | 50% (1 of 2) | 0% (0 of 6) | 13% (1 of 8) | ||||||||
| Onvansertib 30 mg + SoC; N=7 | 50% (1 of 2) | 0% (0 of 5) | 14% (1 of 7) | ||||||||
| Onvansertib (all doses) + SoC; N=15 | 50% (2 of 4) | 0% (0 of 11) | 13% (2 of 15) | ||||||||
| The two partial responses were confirmed on the patients’ subsequent scans. | |||||||||||
Percentage of patients with Grade 4 Treatment-Emergent Adverse Events (TEAEs) | Grade 4 TEAEs | ||||
| Control Arm (SoC alone) | 0% (0 of 7) | ||||
| Onvansertib 20 mg + SoC | 25% (2 of 8) | ||||
| Onvansertib 30 mg + SoC | 0% (0 of 7) | ||||
| Onvansertib (all doses) + SoC | 13% (2 of 15) | ||||
•The combination of onvansertib with SoC FOLFIRI/bev was shown to be well-tolerated and no major / unexpected toxicities were seen
•Two Grade 4 TEAEs of neutropenia were seen in patients receiving 20 mg Onvansertib + SOC
oBoth patients recovered within 7 and 10 days after withholding the study treatment and no dose reductions in subsequent treatment cycles were needed. Both patients are still on trial
Key Baseline Characteristics
•The patients' median age was 53 years (range 35-81), and 54% were male
•68% patients had previously received bev in their first-line treatment
•12 of 21 (57%) evaluable patients remain on trial at the data cutoff date
Conference Call and Webcast
Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024. Individuals interested in listening to the live conference call may do so by using the webcast
link in the "Investors" section of the company's website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company's website following the completion of the call.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com
Media Contact:
Richa Kumari
Taft Communications
551-344-5592
richa@taftcommunications.com
Cardiff Oncology Announces First Patient Dosed in Randomized First-line
RAS-mutated Metastatic Colorectal Cancer Trial (CRDF-004)
RAS-mutated Metastatic Colorectal Cancer Trial (CRDF-004)
- Phase 2 trial in patients with RAS-mutated mCRC will evaluate onvansertib plus SoC versus SoC alone in the first-line setting -
- Pfizer Ignite is responsible for the clinical execution of the trial -
- Initial topline results expected in mid-2024 –
- Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT -
SAN DIEGO, February 29, 2024 -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the first patient was dosed in its randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer (mCRC). The trial, whose clinical execution is being conducted by Pfizer Ignite, Pfizer’s new end-to-end service for biotech companies, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard-of-care (SoC) vs. SoC alone.
“Today’s announcement represents an important milestone for Cardiff Oncology and for patients with RAS-mutated mCRC, who have had no new therapies approved in almost 20 years,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “Based on the encouraging results from our Phase 1b/2 trial in second-line KRAS-mutated mCRC and our preclinical data demonstrating the powerful impact of combining onvansertib and bevacizumab, we believe the addition of onvansertib in the first-line setting has the potential to provide a meaningful improvement to the efficacy of SoC for mCRC patients with a RAS-mutation. We are especially pleased with the opportunity to leverage Pfizer Ignite’s execution capabilities to advance the development of onvansertib. We strongly believe that we are on the cusp of a transformative advance in the treatment landscape for mCRC.”
The Phase 2 trial includes patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib will be added to SoC FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. A total of 90 patients will be randomized in a 1:1:1 ratio to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response and safety.
“We are pleased that the CRDF-004 trial is underway and look forward to providing clinical development support to advance onvansertib in RAS-mutated mCRC, which we believe has the potential to make an impact in patients with metastatic colorectal cancer,” said Adam Schayowitz, Ph.D., MBA, Head, Product Teams, Portfolio & Program Management at Pfizer Oncology, and member of Cardiff Oncology’s Scientific Advisory Board.
Contingent upon the results of CRDF-004, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent. The FDA has agreed that ORR at an interim point is an acceptable
endpoint to pursue accelerated approval of onvansertib from the CRDF-005 trial, with PFS and trend in overall survival being the endpoints for full approval.
Conference Call and Webcast
Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on February 29, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company's website following the completion of the call.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered
representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com
Media Contact:
Richa Kumari
Taft Communications
551-344-5592
richa@taftcommunications.com
AGENDA Q4 2023 Financial Results and ONSEMBLE Trial Data
risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber- attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations.
1. 2023 was a transformational year 2. New data release from 2nd line ONSEMBLE trial 3. Review of financial position AGENDA
August: mCRC September: beyond mCRC
FIRST LINE SECOND LINE
FIRST LINE SECOND LINE
FIRST LINE SECOND LINE
FIRST LINE SECOND LINE
EXISTING DATA NEW DATA FUTURE POTENTIAL FIRST LINE SECOND LINE
NEW DATA 28 DAY CYCLE ENROLLMENT CRITERIA PRIMARY ENDPOINT
NEW DATA Enrollment*
NEW DATA 1st LINE 2nd LINEBev exposed vs bev naïve patients
NEW DATA —
NEW DATA —
NEW DATA —
NEW DATA —
NEW DATA Best response of: PR SD PD
NEW DATA Best response of: PR SD PD
NEW DATA
HIF1aα α Tumor growth Hypoxia α
HIF1aαTumor growth Hypoxia α bevacizumab onvansertib α
FUTURE POTENTIAL EXISTING DATA NEW DATA FIRST LINE SECOND LINE
FUTURE POTENTIAL
FUTURE POTENTIAL Standard of Care
FUTURE POTENTIAL ENROLLMENT CRITERIA ENDPOINTS PFIZER IGNITE 28 DAY CYCLE
Appendix Additional ONSEMBLE data
NEW DATA Bev Naïve Bev Exposed B e v N a ïv e B e v E xp o se d
NEW DATA Best response of: PR SD PD
NEW DATA Control arm
NEW DATA Experimental arm
NEW DATA • • Experimental arm